Identity
- Trade Name
- SINGLE SITE CHOLE KIT 3 FDA UDI
- Generic Name
- Laparoscopic multi-instrument access port, single-use FDA UDI
- Device Name
- Kit Contains: CY050, 5x38cm EPIX INLINE DISSCT 10/BX CB050, 5x38cm EPIX INLINE SCISSORS 10/BX CD003, 5mm RETRIEVAL SYSTEM, 10/BX CA500, EPIX UNIVERSALERSAL CLIP APPLIER 3/BX CNGL2, GelPOINT ADVANCED ACCESS PLATFORM FDA UDI
- Model / Reference
- CK103 FDA UDI
- Description
- Kit Contains: CY050, 5x38cm EPIX INLINE DISSCT 10/BX CB050, 5x38cm EPIX INLINE SCISSORS 10/BX CD003, 5mm RETRIEVAL SYSTEM, 10/BX CA500, EPIX UNIVERSALERSAL CLIP APPLIER 3/BX CNGL2, GelPOINT ADVANCED ACCESS PLATFORM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 20607915125800 FDA UDI
- FDA Product Code
- GCJ FDA UDIHET FDA UDIGEI FDA UDIFZP FDA UDIMDM FDA UDI
- GMDN Term
- Laparoscopic multi-instrument access port, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI884.1720 FDA UDI878.4400 FDA UDI878.4300 FDA UDI878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Ligation clip, metallicEndoscopic electrosurgical handpiece/electrode, monopolar, single-useTissue extraction bagLaparoscopic multi-instrument access port, single-use
Single Site Chole Kit 3 by Applied Medical Resources Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Laparoscopic electrosurgical blunt dissector.
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Applied Medical Resources Corp.
Sources (1)
- FDA UDI a7a7374e-b952-424b-9820-e63a90931c00 34 fields · synced May 30, 2026